Update: The FDA and the Human Germline
As previously reported, an advisory committee of the US Food and Drug Administration is scheduled to hold a public meeting on October 22-23 that will discuss the technique known as mitochondria replacement. Headlines often refer to this as "three-parent IVF." It is also a form of inheritable genetic modification.
Because of the government shutdown, it is unclear whether the meeting will be postponed or held as scheduled. But it's not too late to submit written comments, and the meeting is starting to attract significant attention, both in the media and elsewhere.
On October 9, NPR's Rob Stein presented a report on Morning Edition that featured Marcy Darnovsky of CGS, stressing the established "bright line" against inheritable human genetic modification (IGM) and the reasons not to cross it. Bioethicist Ronald Green discussed both psychological effects on any resulting children and long-term dangers:
If mistakes are made, they won't just be mistakes in the child that is born. But if that child [is a girl and] has children down the line, those children will inherit the mitochondria from that child, and we'll have introduced new genetic diseases into the human population.
The segment also included advocates of mitochondria replacement and scientists working in the field.
Mothers for a Human Future has raised an alert (pdf linked here) on the new technology, which could be the first legally sanctioned form of IGM anywhere in the world. The alert lists ten reasons why we need a global moratorium on IGM "to allow for international public education, conversation, and decision-making on the appropriate global regulatory framework."
Peggy O'Mara is also mobilizing her connections to encourage public participation, and working with both Mothers for a Human Future and CGS to spread the word.
Written comments are due by October 15th, and should be sent to the attention of Gail Dapolito, whose e-mail is gail.dapolito@fda.hhs.gov; the fax number is 301-827-0294.
Previously on Biopolitical Times: